ANNOUNCEMENT

INDIA-EU COOPERATION ON RESEARCH & INNOVATION (R&I)

DBT ANNOUNCES CO-FUNDING PARTNERSHIP UNDER THE

EU FRAMEWORK PROGRAMME ON R&I ‘HORIZON EUROPE’
CALLS 2023-2024
Collaboration in Science, Technology and Innovation (STI) plays an increasingly
important role in the EU-India Strategic Partnership. In line with the EU-India
Strategic Partnership: A Roadmap to 2025, and the Joint Science and Technology
Steering Committee meeting on 12 February 2021, the Department of Biotechnology
(DBT), has identified calls for proposals in the Work programmes 2023-2024 of the
EU R&I Research and Innovation Programme ‘Horizon Europe’, which it considers
of mutual interest and aiming at jointly tackling global challenges.
For this, DBT has established a mechanism outlining the conditions upon which it
will co-fund the successful Indian entity/ies and in which call topics (hereafter Co-
Funding Mechanism or CFM).
The CFM will apply to the call topics earmarked by DBT in areas of pandemic
preparedness and response, brain disorders, biofuels and healthy &
environmentally-friendly food. This notice explains in the different Sections
hereunder how to prepare and submit a co-funded project.
In Section 1 the five call topics earmarked by DBT for co-funding are listed. The list
indicates the exact Call IDs, the opening and closing date of the call, the type of
action provided and the link to the full call text as published in the Horizon Europe
Funding & Tenders Portal.
In Sections 2 and 3, the various modalities of participation that the Indian
applicants have to comply with, including the Administrative and Financial
Considerations (see Annex 1) is outlined.
All proposals have to be submitted to both the Horizon Europe Funding & Tenders
Portal and to DBT. The EU will only evaluate the proposal submitted to its portal.
DBT expects to receive the same copy with in addition all details on the budget the
Indian entity requires for its participation. Budget information to be provided in
prescribed format and in Indian Rupees. In the absence of this, DBT will disqualify
the Indian participants from funding (see Section 4 hereunder).

At the end of the notice, information is provided on how to access and go about
'Horizon Europe' formalities, which also Indian applicants have to comply with
(Annex 2) and on how to find partners (Annex 3).

For the complete call text click Horizon Europe Funding & Tenders Portal
including the general conditions and modalities, and in particular the specific call
conditions on the given call topic. Please read carefully the call text itself, which is
the only legally binding text.

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 CONTENT
SECTION 1: LIST OF CO-FUNDED CALL TOPICS .....................................................4
SECTION 2: MODALITIES OF PARTICIPATION & FUNDING FOR INDIAN
APPLICANTS .............................................................................................................6
1. PARTICIPATION .......................................................................................................6
1. 1. Participation of Indian........................................................................................6
1. 2. Participation of European ..................................................................................7
1.3. Gender Balance ..................................................................................................8
2. ELIGIBILITY .............................................................................................................8
2.1. Indian Entities Eligible to Participate ................................................................8
2.2. European Entities Eligible to Participate ...........................................................8
3. FUNDING ...................................................................................................................9
3.1 Funding by DBT ................................................................................................9
3.2 Funding by EU ...................................................................................................9
3.3 IPR: Ownership, Protection & User rights ......................................................10
4. PREPARATION OF PROPOSAL ..........................................................................10
SECTION 3: REGULATORY & ETHICAL CONSIDERATIONS (IF APPLICABLE) 13
1. Notifications/ Orders issued towards expeditious consideration of various
regulatory aspects in response to COVID-19 pandemic ..................................13
2. Research using hazardous microorganisms, genetically engineered (GE)
organisms & products thereof for R&D purpose .............................................13
3. Human and Animal Subjects Research ............................................................14
4. Authorizations for pre-clinical and/or human clinical trials ............................14
SECTION 4: PROCESS FOR SUBMISSION OF PROJECT PROPOSAL .....................14
1. Submission of proposal on Horizon Europe Funding & Tenders Portal .........15
2. Submission to DBT of the proposal including budget requested from DBT ...15
3. Submission to Horizon Europe Funding & Tenders Portal .............................16
FURTHER INFORMATION ............................................................................................16
ANNEX 1: TEMPLATES FOR ADMINISTRATIVE & FINANCIAL CONSIDERATIONS
...................................................................................................................................17
ANNEX 2: HOW TO ACCESS HORIZON EUROPE PORTAL & FORMALITIES ....22
ANNEX 3: FINDING PARTNERS ...................................................................................23

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SECTION 1: LIST OF CO-FUNDED CALL TOPICS

The CFM applies only to the call topics in HE Work Programme 2023-2024 listed
hereunder:
S. Type
Opening
NO. Title Topic Identifier of Closing Deadline
Date
Action
HEALTH

1. Pandemic preparedness and HORIZON-HLTH- RIA 12 Jan 13 Apr 2023

response: Broad spectrum anti- 2023-DISEASE-03- 2023
viral therapeutics for infectious 04
diseases with epidemic potential
Proposals should address all of the following areas:
 Preclinical work and proof-of-concept/first-in-human studies and early safety and
efficacy trials for testing new or improved anti-viral therapeutics, with a clear
regulatory and clinical pathway. Phase IIb/III phase trials will not be supported.
 Innovative delivery systems and suitable safety profiles for broad use should be
considered when possible. Attention should be paid to critical social factors such as
sex, gender, age, socio-economic factors, ethnicity/migration, and disability.
 Application of novel approaches and widely applicable workflows (e.g. artificial
intelligence) for rapid and reliable identification of broad-spectrum anti-
viraltherapeutics. Read More
2. Validation of fluid-derived HORIZON-HLTH- RIA 30 Mar 19 Sep 2023
biomarkers for the prediction 2024-DISEASE-03- 2023 (First Stage),
and prevention of brain 13-two-stage 11 Apr 2024
disorders (Second Stage)
Proposals should address all of the following aspects:
 Proposals should aim to validate biomarkers that can reliably confirm early stages of the
human brain disorder and guide treatment/ intervention selection.
 Proposals should aim to provide evidence supporting the regulatory acceptance of the
biomarkers.
 Exploitation of existing data, biobanks, registries and cohorts is expected, together with the
generation of new key data.
 Inclusion of patients or patient organisations in the research is strongly encouraged, as to
ensure that their views are considered.
 Sex and gender aspects, age, socio-economic, lifestyle and behavioural factors should be
taken into consideration in the study.
 To enable sharing of samples, quality data and advanced analytical and digital tools,
consideration should be made for using infrastructures already developed at the European or
national level.
 To enable the management of brain disorders, consideration should be made in
demonstrating the gained cost efficiency. Read More

3. Pandemic preparedness and HORIZON-HLTH- RIA 26 Oct 11 Apr 2024

response: Host-pathogen 2024-DISEASE-08- 2023
interactions of infectious 20
diseases with epidemic potential
Proposals should address several of the following areas:
 Identification and characterisation of receptors on the host cell that enable the docking and
internalisation of a virus with a particular emphasis on the diversity of cellular entry
receptors and tissue specificity.

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  Identification and characterisation of viral surface proteins that are capable of interacting
with host target cells.
 Characterisation of the mechanism of viral uptake in the host cell with regard to the
topology and the dynamics of the host receptor – virus ligand interaction.
 Identification of receptor and ligand (sub)units that could be targeted by preventive or
therapeutic intervention. Read More

HEALTHY AND ENVIRONMENTALLY-FRIENDLY FOOD

4 New detection methods on HORIZON-CL6- RIA 22 Dec 12 Apr 2023

products derived from new 2023- 2022
genomic techniques for FARM2FORK-01-
traceability, transparency and 11
innovation in the food system
Proposals are expected to contribute to the development and validation of detection methods of
products obtained through new genomic techniques, including all of the following activities:
 Examine innovative ways and/or specific markers that would allow for distinction between
products resulting from new genomic techniques subject to the GMO legislation and products
that are not subject to the GMO legislation. This should not only entail the detection of specific
mutations, but also of other markers in the genome that are specific for the genotype containing
the mutation/s. The methods should be able to distinguish between identical mutations obtained
through different techniques;
 Development and validation of reliable detection methods including when possible
quantification. Such methods could focus on products with known mutations (i.e. DNA sequence
known) or on products with unknown mutations;
 The proposed detection methods should focus on a wide applicability of all or a subgroup of
products, allowing for a screening approach. These methods should be assessed on pure products
as well as on mixtures typical of food or feed products in the market. Proposals should always
include plant-based products and may include also animal and/or microorganisms-based
products.
 The proposal could also focus on the detection of unintended mutations or insertions (foreign
DNA, CRISPR-Cas sequences, etc);
 The proposals could also include digital/virtual/AI modelling aspects along with the detection
methods alternatives;
 The development and validation of standardized methodologies and the contribution to future
standardisation processes is encouraged. Read More

BIOFUELS

5. Development of smart HORIZON-CL5- RIA 07 May 05 Sep 2024

concepts of integrated energy 2024-D3-02-03 2024
driven bio-refineries for co-
production of advanced
biofuels, bio-chemicals and
biomaterials

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 Proposals should address several of the following areas:
 Development of zero-waste and neutral or negative carbon emission energy-efficient
biorefinery concepts for enabling the production of low-cost advanced biofuels through
co-production of added value bio-based products and bioenergy.
 Conversion of biogenic wastes and residues as well as algae and aquatic biomass
through chemical, biochemical, electrochemical, biological, thermochemical pathways
or combinations of them in highly circular processes are in scope.
 Technology validated in relevant environment is required. International cooperation
with Mission Innovation countries is expected.
 Proposals should provide information and assessment about the economic feasibility and
the potential of scaling-up the technology at commercial scale as appropriate. Read
More
NOTE: DBT will support projects for development and demonstration of zero waste
integrated biorefinery with focus on agriculture wastes/residues as well as algae and aquatic
biomass.

To note that the type of collaborative actions, Research and Innovation (RIA) and Innovation
Actions (IA) are established by Horizon Europe, and to be understood as follows:
 Research & innovation action (RIA) that establishes new knowledge or explores a new or
improved technology, product, process, service or solution.
 Innovation action (IA) that produces plans or designs for new or improved products,
processes or services including prototyping, testing, demonstrating, piloting, large-scale
product validation and market replication.

Technology Readiness Levels

Where the specific call conditions require a Technology Readiness Level (TRL), the following
definitions apply, unless otherwise specified:
 TRL 1 — Basic principles observed
 TRL 2 — Technology concept formulated
 TRL 3 — Experimental proof of concept
 TRL 4 — Technology validated in a lab
 TRL 5 — Technology validated in a relevant environment (industrially relevant environment
in the case of key enabling technologies)
 TRL 6 — Technology demonstrated in a relevant environment (industrially relevant
environment in the case of key enabling technologies)
 TRL 7 — System prototype demonstration in an operational environment
 TRL 8 — System complete and qualified
 TRL 9 — Actual system proven in an operational environment (competitive manufacturing in
the case of key enabling technologies, or in space)

SECTION 2: MODALITIES OF PARTICIPATION & FUNDING FOR INDIAN APPLICANTS

1. PARTICIPATION

1. 1. Participation of Indian

Participation entity in Horizon Europe projects

 Eligibility of Indian entities is defined by DBT.

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  Since the Indian entity is not receiving funding from the EU under Horizon Europe, it is not
required to sign the EU Grant Agreement. It will participate as “Associated Partner” and
mentioned as such in Article 9.1 of the EC grant Agreement.
 This means that the Indian entity is expected to contribute to the smooth implementation of
the project as specified in the consortium agreement.

Formality for Participation

 If you want to participate in a Horizon Europe project proposal, your organisation needs to
be registered in the Participant Register of the Funding & Tenders Portal and have a 9-digit
Participant Identification Code (PIC) number (see registration procedure in Annex 2)

Number of Indian entities per projects

 There is no legal requirement on number of Indian entities in a given project eligibility
condition. Any legal entity/organization (public or private research institute/university)
established in India with expertise in relevant and distinct disciplines. No limit on number of
Indian participants but each partner should be necessary for the execution of the project and
comply with the eligibility conditions. The scientific R&D performing Indian industry may
participate voluntarily in this call with participating Indian industry investing its own
resources or come in collaboration with research/academic organization, but by investing
their own resources (see section 2).
 The call is open to all career groups (i.e. early, intermediate and senior); however, it is
expected that each investigator shall have adequate service tenure to accommodate key
research, coordination, outreach, post completion handholding and maintenance (if any)
responsibilities. Early career investigators are encouraged to participate.
 Each participating legal entity/organisation (public or private research institute/university)
should be represented by at least two investigators.
 The number of Indian project partners should be optimum and correspond to the objectives of
the project. The proposal should clearly demonstrate each partner’s essentiality,
complementarities, and added- value in jointly addressing the topic.
 In case there is more than one Indian legal entity/organization participating in a given project,
it is advised that the Indian participants appoint among them a ‘Lead Scientific Coordinator-
INDIA', who can represent the Indian participants in the consortium vis-à-vis DBT. To
ensure continuity in the project, at least two investigators must represent each participating
legal entity/organization.

1. 2. Participation of European

Number of European entities per projects

 Collaborative research & innovation projects carried out by consortia of organisations
working together on specific research & innovation areas. A consortium must include at
least 3 partner organisations from 3 different Member States or associated countries.
At least one of the 3 partners must be from Member States.
 European Union member states (EU27): Austria, Belgium, Bulgaria, Croatia, Republic of
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain and Sweden.

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  Countries Associated with Horizon Europe: Agreements in place: Albania, Armenia,
Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo, Moldova,
Montenegro, North Macedonia, Norway, Serbia, Tunisia, Turkey and Ukraine.
 The EU is still in the process of association negotiations with Morocco, New-Zealand and
United Kingdom’s (UK) - See updates updated1 - HE association agreements status as of
15.01.2023
 In addition to these three partners, any legal entity from anywhere in the world can be
included in the consortium. Please consult the Horizon Europe programme guide2.

1.3. Gender Balance

Applicants are encouraged to promote equal opportunities in the implementation of the action by
ensuring a balanced participation of women and men at all levels of the research and innovation
teams and in the management structures.

2. ELIGIBILITY

The participating entities/organisations from India have to be a legal entity as per Indian law (Indian
applicants) and the European entities as per the Horizon Europe rules of participation.

2.1. Indian Entities Eligible to Participate

 Government of India supported or recognised Public or Private academia and research organisations
(research institutes & universities);

Indian entities
Academic/Research Partners:

o Public and/or private universities and research organisations must have a well-established
research support system, for basic or applied research; and
o Submission of proof of establishment under Indian statue; recognition documents and
registration at Government of India's Public Finance Management System (PFMS) -
https://pfms.nic.in shall be obligatory.

Ineligible organisations:

o Research centres and academic organisations headquartered and owned outside India and
their subsidiaries in India, or vice versa, are not eligible to receive funding from DBT under
this programme.

2.2. European Entities Eligible to Participate

 Any legal entity is eligible to participate, provided that the conditions laid down in the Horizon
Europe Regulation have been met, along with any other conditions laid down in the specific call
topic3.

1
• https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-
participation_horizon-euratom_en.pdf

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3. FUNDING

3.1 Funding by DBT

DBT will fund the Indian partners/entities in a successful project, as per requirement of the project,
for the project duration up to 3-4 years.

Budget should be commensurate with the essentiality of participation, workload, objectives of the
project and cost of participation.

3.1.1 Eligibility for Funding

Budgeted costs of the project to legal entities subject to obligatory fulfilment of eligibility criteria:

 DBT will support (Grant-in-aid) 100% of the approved budget costs to Government of India
supported or recognised public or private academic institutions or research organisations;

 Eligible costs for funding are: Capital expenditure (equipment's) || Manpower || Consumables
|| Travel (local and international* travel) || Contingency || Overheads || Outsourcing || others.
(Academia can factor in additional sub heads (in other category) such as training &
awareness; workshops; publications; review meetings, etc. under expenditure based on the
requirement of the project).
* The travel of investigator(s) and project staff (s) will be as per prevailing Government of
India guidelines.
3.1.2 Non-Admissible Cost from DBT

i. Prosecution/litigation costs;
ii. Salary of investigators;
iii. Capital expenditure for the purchase of assets such as office furniture, motor vehicles,
Office equipment viz. desktops, laptops, tablets, cell phones, scanners, printers, photocopy
machines, and renovation or extension of facilities such as buildings and laboratories;
iv. Capital expenditure toward technology(ies), demonstration plants and associated field
equipment(s), hardware, software etc. for test and analysis from consortium partner(s) from
abroad;
v. Expenditure toward rental and utilities;
vi. International travel to countries other than the one participating within the consortia in a
particular call topic of Horizon Europe;
vii. Mere attendance at conferences/ symposiums/ congresses

3.2 Funding by EU

Funding of European partners is as per Horizon Europe rules of participation and in function of type
of action [RIA & IA]4.

3
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/wp-call/2021-2022/wp-13-general-
annexes_horizon-2021-2022_en.pdf (page 5)
4
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/programme-
guide_horizon_en.pdf

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3.3 IPR: Ownership, Protection & User rights

 IPR legislation and other rules are often crucial for participants in research projects, as they may
have a deep influence on the way in which the knowledge can be shared during a project
development, and in which project results can be commercially used.
 The participants shall jointly develop a Consortium Agreement (CA). The CA is a specific
agreement to be concluded between the participants in joint research, defining, among other
things, ownership, protection, user rights for research and development purposes, exploitation
and dissemination, including arrangements for joint publication, the rights and obligations of
visiting researchers and dispute settlement procedures. The CA shall also address foreground and
background information, licensing and deliverables.
 The IPR issues for all the proposals need to satisfy the S&T agreement between EU and India

4. PREPARATION OF PROPOSAL

The Indian and European participants must formulate a joint proposal, according to the requirements
and templates provided by respectively Horizon Europe Funding & Tenders Portal format5 and
DBT's administrative and financial requirements (see annex 1). Complying with the formats and
templates of Horizon Europe and DBT for the Indian partners is mandatory. Indian entities should
participate as an Associated Partners.

The Horizon Europe proposal consists of two main parts:

 Part A: the Administrative Forms containing general information on the project (title,
abstract, and keywords), the consortium (basic administrative data, contact persons,
declarations) and the budget overview.
 Part B: the Technical Annex containing the detailed description of the planned research and
innovation project. The structure is based on the evaluation criteria (cite them here) as
provided in the proposal template for a RIA/IA.

How to Add Associated Partners to a Proposal on the Funding & Tenders Portal
Entities based in India can participate to Horizon Europe projects by applying under the participant
role of “Associated Partners” (AP).
This is a step-by-step guide on (to be done via European proposal coordinator):
o how to add an AP to a proposal on the Portal
o how to include the budget of an AP on the Portal
o how to deal with the budget table for Lump Sum projects

5
https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/temp-form/af/af_he-ria-ia_en.pdf

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11
“Financial Contribution”. Insert here the total amount that the Indian entity participating as an AP
intends to request to DBT.
In general, this budget category is used for any financial contribution expected to be received/ already
received from other sources for being used specifically for the same action as the one submitted for
funding under Horizon Europe (e.g. funding from DBT).

Tasks attributed to the Associated Partner must be described in the technical description (Part B) of
the project. If you wish, you can also include in this section the estimated budget of the entity (not
mandatory).

Indian participants prepare budget (in Rupees) according to DBT requirements and templates

 Indian participants MUST submit detailed financial plan in Indian Rupees (₹) for duration of
the project to DBT only.
 The detailed Indian financial plan for each Indian participant in the project must be specified
according to format provided by DBT in Annex 1: Indian academic partners must use "Budget
Format - Academic Partner" (at para 7.2).

DBT's budget calculation for Indian participants

Indian participant must ensure that each Indian participant follows budget format proposed by the
DBT.

Direct Costs:

1) Manpower cost: as per the requirements of the project (emoluments will be as per prevailing
Gov. of India norms);
2) Mobility of investigator(s) & project staff(s): for visit(s) and work related to the project to
be undertaken by Indian investigator(s) & project staff(s) in Europe, the cost of travel and
man-days of stay in European countries (i.e. round-trip international travel by economy class,
admissible insurances, local transport, boarding and lodging) must be justifiably budgeted by
respective Indian organisation for each year, at 7.1 and 7.2 (as applicable) of Annex 1. The
travel of investigator(s) and project staff (s) will be as per prevailing Government of India
guidelines.
Institution hosting the collaborating investigator(s) & project staff(s) of other consortium
participants, shall provide research facility and research resources to accomplish defined
objectives and if required, this can be reflected in each participant budget adequately.
3) Overhead/Indirect Cost: overhead expenses payable to legal entity/organization for Indian
partners, up to 10% of the total project cost for educational institutions and up to 8% for
laboratories and institutions under central Government Departments/Agencies as per
prevailing Gov. of India norms.

||to be noted ||
 Indian entity(ies) will submit detailed financial plan in Indian Rupees only to DBT
 The budget that DBT provides to Indian participants does not cover expenses incurred
by the European and other countries’ applicants in the consortium.
 Indian entity(ies) will not sign EC’s Grant Agreement but considered as ‘Associated
Partners’.

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SECTION 3: REGULATORY & ETHICAL CONSIDERATIONS (IF APPLICABLE)

1. Notifications/ Orders issued towards expeditious consideration of various regulatory

aspects in response to COVID-19 pandemic

 Rapid Response Regulatory Framework for COVID-19 to deal with applications for
development of Vaccines, Diagnostics, Prophylactics and therapeutics
 http://dbtindia.gov.in/sites/default/files/uploadfiles/om_covid19%20April%202020.pdf
 Interim Guidelines on Laboratory Biosafety to Handle COVID-19 Specimen for R&D
Purpose
 https://ibkp.dbtindia.gov.in/Content/FlashPDF/OM_Interim_Guidance_COVID.pdf
 Rapid Response Regulatory Framework for COVID-19 Vaccine Development
 https://ibkp.dbtindia.gov.in/Content/FlashPDF/Checklist_Recombinant%20Vaccine%20_
COVID%2019.pdf
 Guidelines for sharing of Bio-specimen and Data for Research related to COVID-19
 https://niti.gov.in/sites/default/files/2020-04/Guidelines-for-sharing-of-Biospecimen-and-
data-for-research-related-toCOVID-19..pdf
 SOP Template for Ethics Review of Biomedical and Health Research During Covid-19
Pandemic, 2020
 http://ethics.ncdirindia.org//asset/pdf/SOP_Template_EC_COVID19.pdf
 National Guidelines for Ethics Committees Reviewing Biomedical & Health Research
During Covid-19 Pandemic, 2020
 http://ethics.ncdirindia.org//asset/pdf/EC_Guidance_COVID19.pdf

2. Research using hazardous microorganisms, genetically engineered (GE) organisms &

products thereof for R&D purpose

In India, research using hazardous microorganisms, genetically engineered (GE) organisms &
products thereof are governed under Rules, 1989 (Rules for the Manufacture, Use/Import/Export and
Storage of Hazardous Micro Organisms/ Genetically Engineered Organisms or Cells) of
Environment (Protection) Act, 1986, according to which, necessary intimation/ recommendation/
authorization from concerned Institutional Biosafety Committee (IBSC), Review Committee on
Genetic Manipulation (RCGM) & Genetic Engineering Appraisal Committee (GEAC) is obligatory
based on type & scale of research operations.

Further guidance on regulatory considerations can be obtained from:

 Guidelines and Handbook for IBSCs, 2011

http://dbtindia.gov.in/sites/default/files/uploadfiles/Guidelines%20_Handbook_2011.pdf
 Regulations and Guidelines on Biosafety of Recombinant DNA Research & Biocontainment,
2017
http://www.dbtindia.nic.in/wp-content/uploads/Draft-Biosafety-Regulations-and-
Biocontainment-Guidelines-2017-FF.pdf
 Recommendations for Streamlining the Current Regulatory Framework, 2005
http://www.moef.nic.in/divisions/csurv/geac/draftreport_rpharma.pdf

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3. Human and Animal Subjects Research

DBT and the European Commission are committed to ensure that projects involving human or
animal subjects are protected from research risks in compliance with the rules and policies in
respectively the EU and India (ICMR/DBT policies).

All projects recommended for award that involve human or animal subjects will undergo Horizon
Europe ethics review6 as well as a review by the Indian Bioethics Committees prior to award request.

For information on ICMR policies, please consult:

 Handbook on National Ethical Guidelines for Biomedical and Health Research Involving
Human Participants, 2018
http://ethics.ncdirindia.org//asset/pdf/Handbook_on_ICMR_Ethical_Guidelines.pdf

India PIs of the consortium should apply to their institutional review boards (IRBs)/ institutional
ethics committees (IECs) at the time of submission of proposal to obtain necessary bioethics
approvals from all involved institutions.

4. Authorizations for pre-clinical and/or human clinical trials

While exploring vaccine developmental studies in India, Investigators must satisfy regulatory and
ethical provisions adopted under:

 Drugs and Cosmetics Rules, 1945 (as amended from time to time) of Drugs and Cosmetics
Act, 1940
 Committee for the purpose of Control and Supervision of Experiments on Animals.
http://cpcsea.nic.in/Auth/index.aspx
 Schedule ‘Y’ of Drugs and Cosmetics Rules, 1945 || Requirements and Guidelines for
Permission to Import and/or Manufacture of New Drugs for Sale or to undertake Clinical
Trials: http://cdsco.nic.in/html/D&C_Rules_Schedule_Y.pdf
 Guidance for Industry on Preparation of Common Technical Document for
Import/Manufacture and Marketing Approval of New Drugs for Human Use (New Drug
Application-NDA):
http://www.cdsco.nic.in/writereaddata/CDSCO-GuidanceForIndustry.pdf
 Handbook: Good Laboratory Practice (GLP). Quality practices for regulated non-clinical
research and development, 2nd ed. Geneva, World Health Organization, 2009 ||
http://www.who.int/tdr/publications/documents/glp-handbook.pdf
 Clinical Trials Registry of India (CTRI) – India
http://ctri.nic.in/Clinicaltrials/login.php

SECTION 4: PROCESS FOR SUBMISSION OF PROJECT PROPOSAL

All proposals with Indian applicants should be submitted to both Horizon Europe Funder & Tenders
portal and to DBT.

6
https://webgate.ec.europa.eu/funding-tenders-
opportunities/display/OM/Special+procedures%3A+Ethics+review%2C+security+scrutiny%2C+Ownership+control+check

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 1. Submission of proposal on Horizon Europe Funding & Tenders Portal

A joint proposals must be submitted electronically using the electronic submission system of the
Funding & Tenders Portal7. This task will be done by designated European Project Coordinator.
Please ensure he/she gets all the required information from Indian participant(s) on time. In
preparation thereof, Indian applicants should have their Personal Identification Code (PIC). See
Annex 2 hereunder. For more information, see Proposal Submission Service User Manual8.

2. Submission to DBT of the proposal including budget requested from DBT

The Indian participant(s) must submit the complete proposal, (Part A + Part B) and same as
submitted on the Horizon Europe Funding & Tenders Portal), as one single consolidated PDF file +
DBT’s administrative and financial form to DBT within 7 working days of closer of call deadline.

Pandemic preparedness and HORIZON-HLTH-

response: Broad spectrum anti-viral 2023-DISEASE-03-
therapeutics for infectious diseases 04
with epidemic potential
Validation of fluid-derived HORIZON-HLTH-
biomarkers for the prediction and 2024-DISEASE-03-
prevention of brain disorders 13-two-stage
icone@dbt.nic.in
(A) Pandemic preparedness and HORIZON-HLTH-
response: Host-pathogen interactions 2024-DISEASE-08-
of infectious diseases with epidemic 20
potential
New detection methods on products HORIZON-CL6-
derived from new genomic 2023-FARM2FORK-
techniques for traceability, 01-11
transparency and innovation in the
food system
Development of smart concepts of HORIZON-CL5-
integrated energy driven bio- 2024-D3-02-03
(B) refineries for co-production of sangita.kasture@nic.in
advanced biofuels, bio-chemicals and
biomaterials

Please note that the proposal will be disqualified if not submitted to DBT to above indicated email
ID by indicated date. Absence of timely submission or any discrepancy found in the proposal
submitted at Horizon Europe Funding & Tenders Portal and to DBT will result in disqualification
from consideration by DBT for funding.

After completion of HE peer review process, Indian participant(s) in shortlisted HE proposals will be
requested to submit:

 A duly signed (by the Lead Coordinator-INDIA) and transmitted (by the Utmost Authority of
the organization) short covering letter introducing the application, along with complete
proposal to the concerned DBT contact point.

7
https://webgate.ec.europa.eu/funding-tenders-opportunities/pages/viewpage.action?pageId=1867927
8
https://ec.europa.eu/research/participants/data/support/sep_usermanual.pdf

15
  A comprehensive facts about administrative, statutory, ethical and financial considerations
(including diligent justification for proposed budgetary requirements) in the form of checklist

3. Submission to Horizon Europe Funding & Tenders Portal

 In order to submit a proposal, any applicant (from Europe or India) needs to be registered by
the European Commission and obtain for this purpose a Personal Identification Code also
called PIC: see registration procedure in Annex 2).

 Online guidance is also provided on how to fill in the administrative forms (Part A).

 Proposal templates for the technical annex can be downloaded from the system. The technical
annex and any additional annexes have to be uploaded as PDF documents.

 The Templates to comply with for DBT requirement are available on DBTs website only.

For more details see: https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/how-to-

participate/how-to-participate/1

FURTHER INFORMATION
DBT contacts:

Pandemic preparedness and HORIZON-HLTH-

response: Broad spectrum anti-viral 2023-DISEASE-03-
therapeutics for infectious diseases 04
with epidemic potential
Validation of fluid-derived HORIZON-HLTH-
biomarkers for the prediction and 2024-DISEASE-03-
prevention of brain disorders 13-two-stage Dr. Abhishek Singh,
(A) Pandemic preparedness and HORIZON-HLTH- Scientist ‘C’, DBT
response: Host-pathogen interactions 2024-DISEASE-08-
icone@dbt.nic.in
of infectious diseases with epidemic 20
potential
New detection methods on products HORIZON-CL6-
derived from new genomic 2023-FARM2FORK-
techniques for traceability, 01-11
transparency and innovation in the
food system
Development of smart concepts of HORIZON-CL5- Dr. Sangita M.
integrated energy driven bio- 2024-D3-02-03 Kasture, Scientist ‘F’,
(B) refineries for co-production of DBT
advanced biofuels, bio-chemicals and
sangita.kasture@nic.in
biomaterials

EU Contacts:
 DELEGATION-INDIA-RI@eeas.europa.eu

16
ANNEX 1: TEMPLATES FOR ADMINISTRATIVE & FINANCIAL CONSIDERATIONS
As this is a fast track procedure, DBT requests Indian Investigator or in the case of more Indian partners in
one proposal, the Lead Coordinator-INDIA, to provide information proforma allowing DBT to speed up the
granting time, in the interest of quickly staring the research work, as required by the special call for
Expressions of Interest.

General Instructions:
 Make sure that all investigators shall thoroughly understand the call text and requirements of participation
& funding, before attempting to fill this proforma

 All fields are mandatory. Therefore, all sections of this proforma must be completed. If the space provided
is not sufficient, attach additional supporting materials as necessary. Page numbering and headings of any
supplementary material must match corresponding sections in filled-in proforma.
 Kindly read the footnotes and furnish information/ data, accordingly.
 Each field demands distinct attention, and diligent answer. Therefore, avoid mere replication of
information
 Project shall not be pursued if it is incomplete or any of the requirements mentioned herein missing

 To accomplish official considerations, successful proposal(s) shall be asked to submit comprehensive facts
about administrative, statutory, ethical and financial considerations (including diligent justification for
proposed budgetary requirements).

SR. PARTICULARS
NO.

1.0 GENERAL INFORMATION

1.1 Duration of the Project [in months]

1.2 Proposed cost of the project [Cumulative (non-recurring & recurring), as well as Segregated
project cost proposed for Indian and EU participants || In INR]
1.3 Objectives of the proposal [only one-two liner, must be interdependent, and to be submitted as
bullet points || NMT 100 words]
2.0 Status of EACH of the INDIAN participating legal entity/organization and, fulfilling various
registration requirements, as explained in participation modalities.

Name of the participating Organization  Organization Organization

1 2…
[Select the one, Public or private university and/or research
whichever is applicable] organization

[OR]

Private R&D performing institution; Not-for-

profit, NGO/ VO/ Trust/ Research foundation

[Pl. mark “X” for Proof of establishment under Indian statue

whichever is Proof of registration at GoI Public Finance
AVAILABLE] Management System (PFMS)
Proof of registration at ‘NGO DARPAN’ of
NITI Aayog
Certificate of registration under Society
Registration Act
VALID SIRO certificate for in-house R&D
recognition
Audited account statements for the past

17
 three years
Certificate of Incorporation issued under
Companies Act
Firm’s Memorandum of Association

3.0 Whether EACH of the INDIAN Project Investigator has valid service tenure to accommodate
key research and other responsibilities assigned by the consortium? [-- YES/NO --]

- If yes, provide valid answer for the same with date of superannuation [NMT 30 words]

- If no, Provide details of precautionary approach to be followed in case of exigency

[NMT 80 words]

4.0 WORK DIVISION

4.1 Provide explicit ROLE(s) assigned to EACH participating investigator (Indian & EU
counterparts) to be involved in this project.
Sr. NAME OF THE PARTICIPATING IN THE ORGANIZATION’S ROLE(S)
NO. INVESTIGATOR CONSORTIUM AS ABBREVIATED ASSIGNED
NAME
(Project Coordinator/ Lead
Coordinator-INDIA/CO-PI/CO-I)
1
2…

4.2 Provide explicit RESPONSIBILITY(ies) assigned to EACH participating investigator (Indian

& EU counterparts) to be involved in this project.
Sr. NAME OF THE RESPONSIBILITIES
NO. INVESTIGATOR ASSIGNED
1
2…
4.3 Provide explicit TASK(s) assigned to EACH participating investigator (Indian & EU
counterparts) to be involved in this project.
Sr. NAME OF THE TASKS
NO. INVESTIGATOR ASSIGNED
1
2…

5.0 IMPORTANCE, EXPECTATION & OUTCOME

5.1 How the project relates to India specific and global aspiration?
5.2 Describe briefly the importance of proposed research & innovation for the scientific community,
and the impact you expect from the project on research, training and teaching in your
field/discipline in short and/or long term
5.3 Provide explicitly the anticipated provisions toward ensuring country’s preparedness in
mitigating various health emergencies such as “COVID-19” caused by SARS-CoV-2.

[Please note that while seeking this clarity our expectations are way beyond training of human
resource or establishing laboratory infrastructure]
5.4 Explain what differentiates your project’s likely outcome, and provides the highest added value
(in quantitative and qualitative terms) for INDIAN industries, SMEs, policy makers, society, etc.
in short and/or long term

[In a two page note you should make it clear where your project is positioned in the value chain

18
 and state which & how the realistic value will be created overtime]
6.0 DESCRIBE THE FOLLOWING

[Kindly note that the IPR issues need to be in compliance with the S&T agreement between EU
and India]
6.1 Provide details of each of the IPs (patent, copyright, trademarks etc.) within the consortium
(including of outsourcing partners) already “PROTECTED”, so far; and commercial ownership
of the same (as applicable) which would likely to impact the project under consideration
6.2 Provide details of each of the knowhow, models, algorithms, technology(ies) and technology
interventions ‘within the consortium (including of outsourcing partners)’ already
“GENERATED”, so far; which would likely to impact the project under consideration
6.3 Summary of your freedom to operate above mentioned knowhow(s) and/or IPs during the tenure
and beyond the tenure of the project
7.0 BUDGETARY REQUIREMENTS
7.1 Details of Consolidated budget proposed
(Rs. In lakhs)
Heads Year Year Year Total
I II III…
Equipment(s)
Manpower
Consumables
Travel
a. Domestic
b. International *
i. Expenditure for travel of investigator(s) to EU
ii. Expenditure for travel of project staff(s) (preferably
registered PhDs and/or Postdocs) to EU
iii. Expenditure for stay of investigator(s) in EU
iv. Expenditure for stay of project staff(s) (preferably
registered PhDs and/or Postdocs) in EU
c. Subsistence cost for visiting Indian counterpart
investigator(s) and/or project staff(s) within India
Contingency
Overheads
Outsourcing
Other (Provide details)……
Total
*The travel of investigator(s) and project staff (s)will be as per prevailing Government of India
guidelines

(N.B: Academia can factor in additional sub heads (in other category) such as training &
awareness, review meeting, consultancy charges, field & farm expenses, etc. based on the
requirement of the project.)
7.2 Details of Investigator-wise and/or organization wise & year wise final budget proposed:
[Critically review the budget requirements, ensuring every possibility of using existing resources
& communication technologies or possibly sharing the same from alternative sources
(outsourced) without impacting time and efforts to achieve the goal]

(Rs. In lakhs)
Heads Year Year Year Total
I II III…
Equipment(s)
Manpower
Consumables

19
 Travel
a. Domestic
b. International*
i. Expenditure for travel of investigator(s) to EU
ii. Expenditure for travel of project staff(s) (preferably
registered PhDs and/or Postdocs) to EU
iii. Expenditure for stay of investigator(s) in EU
iv. Expenditure for stay of project staff(s) (preferably
registered PhDs and/or Postdocs) in EU
c. Subsistence cost for visiting Indian counterpart
investigator(s) and/or project staff(s) within India
Contingency
Overheads
Outsourcing
Other (Provide details)……
Total
*The travel of investigator(s) and project staff (s)will be as per prevailing Government of India
guidelines

(N.B: Academia can factor in additional sub heads (in other category) such as training &
awareness, review meeting, consultancy charges, field & farm expenses, etc. based on the
requirement of the project)
8.0 UNDERTAKING & ENDORSEMENTS

8.1 a) The research work proposed in the scheme/project entitled "..........." does not in any way
duplicate the work already done or being carried out elsewhere on the subject.

b) Certified that above information is true to the best of our knowledge

[Name, Signature and Stamp of Lead Coordinator-INDIA (On behalf of all participating
investigators)]

Forwarded by
[Name, Signature & Stamp of Executive Head of Institution/ Organization/ University]

8.2 Enclose a letter of collaboration and submission of joint proposal (with the project title) from
Project Coordinator

8.3 Endorsement by the Head of the legal entity/organization: (to be submitted on letter head in
support of individual participating investigator of the concerned organization as per the
proforma placed below)

Endorsement by the Head of the Organization

To be submitted on letter head in support of individual participating investigator

Project Title:

I. Certified that the institution welcomes participation of

Dr._____________________________ as the Principal Investigator and
Dr.____________________________ as the Co-Principal Investigator (Co-PI) or Co-
Investigator (Co-I) for the project and, in the unforeseen event of discontinuance by the
Principal Investigator, the Co-PI or Co-I will assume the responsibility of the fruitful
completion of the project [with due information to the Department of Biotechnology (DBT)].

20
II. Certified that all resources (infrastructure, techno-scientific, administrative, etc.) as per the
terms and conditions of the grant, will be extended to investigator(s) throughout the duration of
the project.

III. Organization assumes to undertake the financial and other management responsibilities of
the project.

IV. Certified that comprehensive appraisal pertaining to administrative, financial, ethical,

regulatory & statutory requirements has been made towards participation of this organization
through this project, beforehand.

V. We thoroughly understood the modalities of participation & funding, and shall abide to it.

VI. We hereby commit to obtain all applicable (central & state) environmental, regulatory &
statutory as well as local governmental authorizations, prior to the commencement of relevant
research, innovation & translation activities.

VII. We agree to accept the terms and conditions of Department of Biotechnology, Govt. Of
India.

VIII. The details & information given in the project proposal are true & factual.

Date:
Name & Signature with Stamp
of Head of the Organization
Place:

21
ANNEX 2: HOW TO ACCESS HORIZON EUROPE PORTAL & FORMALITIES
How to Participate:

By selecting the “How to Participate” tab on the Horizon Europe Funding & Tenders Portal “Home”
page, researchers and innovators will be directed to a page that provides easy access and instructions
for using key parts of the portal (see screen shot below):

 Create an Account
 Register an Organization
 Find Partners
 Find a Call for Proposals
 Submit a Proposal

22
ANNEX 3: FINDING PARTNERS
The starting point is to consider partners with whom you already have direct or indirect connections.
As participation in a Horizon Europe call requires an interdisciplinary and/or inter-sectoral approach
for a challenge to be addressed appropriately, it may become necessary to look for partners outside
the usual circle of contacts.

Hereunder you will find a list of European services that assist in finding the right partners:

Partner search tools

Partner Search for Find partners for your project ideas among the organisations
organisation profiles on the registered in the Funding & Tenders Portal of the European
EC platform Commission.
Find partners with the help The Enterprise Europe Network online database contains over 2,500
of Enterprise Europe technology profiles (offers and requests) from companies and R&D
Network organisations from over 60 countries in Europe and beyond.
Guide to an adequate
partner search Horizon Europe: Guide to an adequate partner search

Horizon Europe Funding & Tenders Portal: search by call topics where
Expressed Interest organisations have participated or expressed interest in participating in the
future.
Partner Search and Matchmaking platform to find partners and project
euMatch 2.0
initiatives to participate in H2020 supported health related projects.
NCP Network National Contact Points for Horizon Europe

23